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SOPs

Research Standard Operating Procedures are below.  For template documents and guidance click here

SOP_001      Prod & Mgmt of Proc Docs UHBW v3.3 11SEP2023

SOP_002     Research Sponsorship at UHBW_v4.2 15FEB2023

SOP_003      Developing and Designing your study UHBW_v1.5 16FEB2023

SOP_004     SOP_004 Writing a Research Protocol UHBW_V1.8 02AUG2023

SOP_006      Management of Investigational Medicinal Products UHBW_v1.8 16FEB2023

SOP_007     Research Training UHBW_v1.8 13NOV2023

SOP_008      Investigator Oversight of Research UHBW_v3.1 16FEB2023

SOP_009      Research Safety Reporting UHBW_v12 20NOV2023 

SOP_010      Monitoring Oversight of Research UHBW_v4.2 16FEB2023

SOP_011      Validation and backup of computer systems used in research UHBW_v2.1 16FEB2023

SOP_012     Study data UHBW_v3 26JAN2024

SOP_013      Research Study Samples UHBW v2.2 12OCT2023

SOP_014     Essential Research Documents UHBW_v2.3_15FEB2023

SOP_015      Archiving of Research Doc UHBW_V2.3 01MAY2024

SOP_016      Research Contracts and Vendor Selection UHBW_v3.0 27SEP2023

SOP_017     Capacity and Capability review UHBW_v3.2 16FEB2023

SOP_018      Management of Breaches in Research UHBW v2.4 17OCT2023

SOP_019     UHBW sponsored research amendments v2.1 20FEB2023

SOP_020     UHBW Hosted Research Amendments_V1.3 21FEB2023

SOP_021     UHBW review of clinical trials involving ATIMPs v3.2 10JAN2024 

SOP_022     Extended roles of non medical clinicians UHBW_v1.4 12DEC2023

SOP_024      Setup and Management of Phase I Trials UHBW_V1.3 04JAN2024

SOP_025      Applying for use of UHBW CRF v2.1 22FEB2023

SOP_027      Informed consent for research purposes UHBW_v1.4 22JUL2024 

SOP_028      Source_ Data_Documentation_v1.2 03MAY2024

SOP_029      Dose escalation in research studies at UHBW v1.0 02FEB24